At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 25 enrolled
Drug / intervention
RIXUBIS: On-Demand +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase IV Multi-Center, Prospective, Interventional, Post-Marketing Study in Hemophilia B Patients in India Receiving RIXUBIS as On-demand or Prophylaxis Under Standard Clinical Practice
In Brief
A Phase 4 clinical trial evaluating RIXUBIS: On-Demand and RIXUBIS: Prophylaxis for Hemophilia B. Completed, enrolled 25 participants across 1 site.
Detailed Summary
The purpose of this study is to characterize the safety and describe the effectiveness of RIXUBIS in routine clinical practice.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia B
CountriesIndia
CollaboratorsBaxalta Innovations GmbH, now part of Shire
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartDec 2018
Primary CompletionAug 2021
TodayJul 2026
First PostedJun 21, 2018
Enrollment StartDec 7, 2018
Primary CompletionAug 11, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.0 years ago
Interventions
RIXUBIS: On-Demandbiological
RIXUBIS used under standard clinical practice in India: On-Demand treatment.
RIXUBIS: Prophylaxisbiological
RIXUBIS used under standard clinical practice in India: Prophylaxis treatment.